Pharmaceutical industry
Merck & Co., Inc., a leading research-driven pharmaceutical company, has announced that the Food and Drug Administration (FDA) has granted six additional months of marketing exclusivity to Pepcid (famotidine) in response to a supplemental new drug application (sNDA) submitted by the company. This decision delays FDA approval of generic famotidine
Pharmaceutical industry
The US Food and Drug Administration has given the green light to a new, easier-to-use version of the AIDS drug ddI, which may ease patient complaints about the medicine's difficulty to swallow. The new version is a once-a-day capsule, Videx EC, which eliminates the need for patients to
Pharmaceutical industry
The Food and Drug Administration has approved RU-486, also known as mifepristone, the abortion pill, after several years of deliberation. The decision was met with a mix of responses from proponents and opponents of abortion, with the FDA commissioner, Jane Henney, stating that the approval was based on a thorough
Pharmaceutical industry
The Senate-passed version of the bill, which would allow pharmacies and wholesalers to import prescription drugs from countries where prices are lower, has gained the support of House Republican leaders. This development suggests that Congress and President Clinton may be on the verge of agreeing on the legislation. The bill,
Drugs
Faulding, an international pharmaceutical and health care company, announced that its US-based Purepac oral generic business has received final approval from the FDA to manufacture and market bisoprolol fumerate and hydrochlorothiazide tablets, a generic version of Lederle's Ziac(R) brand tablets. The product is indicated for the treatment
Drugs
Gliatech Inc.'s Board of Directors has announced the receipt of an interim report on the results of its external investigation, which revealed concerns regarding the Company's post-approval U.S. clinical study of ADCON(R)-L. While the investigation is ongoing, the Board has concluded that certain
Pharmaceutical industry
Regulated pharmaceuticals and their metabolites are making their way into waterways, posing an environmental and health concern. The Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) are working together to monitor and regulate the release of these substances into the environment. Recent studies have shown that a
Drugs
The Food and Drug Administration has ordered a warning pamphlet to be attached to each bottle of Lotronex, a drug prescribed for women with irritable bowel syndrome, due to reports of rare but serious side effects. The decision, the first of its kind, came after 15 patients experienced severe side
Pharmaceutical industry
Recent updates from the FDA and USDA cover a wide range of topics, including the approval of new animal drugs, food additive petitions, and regulatory amendments. The updates are reflected in various Federal Register notices issued in August 2023. Notably, the FDA has issued several notices announcing the approval of
Drugs
The U.S. Food and Drug Administration (FDA) has approved Tripedia, a diphtheria and tetanus toxoids and acellular pertussis vaccine, for the fifth consecutive dose in the childhood immunization series against diphtheria, tetanus, and pertussis. This approval enables the pediatric healthcare community to use the leading acellular pertussis vaccine for
Pharmaceutical industry
During a fall 1999 audit, inspectors from the New York District Office uncovered several critical issues at Thames Pharmacal, including stability failures and a dispute over field alert filings. The inspection, which lasted from September 9 to October 14, 1999, resulted in a nine-page 483 and a warning letter dated
Pharmaceutical industry
FDA concerns over stability testing at Caraco Pharmaceuticals have led to a warning letter citing several significant issues. The agency criticizes the company for failing to establish and follow an adequate stability-testing program, with findings from a May-June 1999 audit being repeated during a recent inspection. The Detroit district also
